ARDX Surges After-hours, MBVX Abuzz, TRVN Keeps Its Focus

10/12/2017 1:15 AM ET

Today's Daily Dose brings you news about positive results from Ardelyx's phase III study of Tenapanor for irritable bowel syndrome with constipation; Flexion's stock offering; Merck's decision of not to submit applications for regulatory approval for its anti-cholesterol drug Anacetrapib; Trevena's reduction in workforce and MabVax's progress in phase I study of a radioimmunotherapy product for pancreatic cancer.

Read on…

Shares of Ardelyx Inc. (ARDX) surged more than 36% in extended trading on Wednesday, following positive results from its second phase III study of Tenapanor for irritable bowel syndrome with constipation (IBS-C).

In the study, dubbed T3MPO-2, the primary endpoint of combined responder rate for six of 12 weeks showed that a greater proportion of Tenapanor-treated patients compared to placebo-treated patients had at least a 30 percent reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements in the same week for at least six of the 12 weeks of the treatment period.

The Company reported positive results from the first of two phase III trials evaluating Tenapanor for the treatment of patients with irritable bowel syndrome with constipation, dubbed T3MPO-1, in May of this year.

Based on positive results from two positive Phase 3 trials, Ardelyx is on track to submit a New Drug Application to the FDA for Tenapanor for the treatment of IBS-C in the second half of 2018.

The most commonly reported side effect of Tenapanor is diarrhea. In the T3MPO-1 study, the rate of diarrhea was 14.6% in the treatment-arm and 1.7% for placebo. In the T3MPO-2 study, the rate of diarrhea was 16% in the treatment-arm and 3.7% for placebo.

ARDX closed Wednesday's trading at $5.40, unchanged from the previous day's close. In after-hours, the stock was up 36.11% to $7.35.

Flexion Therapeutics Inc. (FLXN) has offered to sell 4.8 million shares of its common stock at a price of $25.50 each.

The gross proceeds from this offering are expected to be approximately $122.4 million.The offering is expected to close on or about October 16, 2017, subject to customary closing conditions. The underwriters have a 30-day option to purchase up to 720,000 additional shares of its common stock.

The Company received FDA approval for Zilretta, the first intra-articular, extended-release treatment for patients with osteoarthritis related knee pain, on October 6, 2017.

FLXN closed Wednesday's trading at $26.21, down 3.53%.

Merck & Co. (MRK) has decided not to submit applications for regulatory approval for its anti-cholesterol drug Anacetrapib, following a thorough review of its clinical profile, including discussions with external experts.

In a study, dubbed REVEAL, treating high-risk patients with Anacetrapib lowered the risk of a first major coronary event by 9% compared with placebo.

MRK closed Wednesday's trading at $63.78, down 1.05%.

MabVax Therapeutics Holdings Inc. (MBVX) has initiated patient enrollment at a second site, Memorial Sloan Kettering Cancer Center, in a Phase 1 clinical trial evaluating MVT-1075, a new radioimmunotherapy product, for patients with locally advanced or metastatic adenocarcinoma of the pancreas or other CA19-9 positive malignancies including colon and lung cancers.

The Company expects to report interim results from the MVT-1075 Phase 1 clinical trial before the end of the year.

MBVX closed Wednesday's trading at $0.78, up 23.79%.

In a bid to focus its resources on commercial strategy, Trevena Inc. (TRVN) is reducing its workforce by approximately 30 percent, or 21 full time employees, predominantly from its research team.

The Company is halting its investment in early stage research, and intends to complete the ongoing Phase 1 trial of TRV250 for acute migraine, after which it will assess options for further development of this asset, as well as for its series of novel S1P modulators for neuropathic pain.

Data from the ongoing Phase 1 study of TRV250 is expected to be reported later this year. The New Drug Application for OLINVO is expected to be submitted to the FDA this month. OLINVO is being developed for treating moderate-to-severe acute pain following bunionectomy and abdominoplasty.